FDA.reportPublic FDA data

Calamine Plus Pramoxine HCl

Product NDC
41520-184
Requested package NDC
41520-184-41
11-digit product format
415200184
Labeler code
41520
Product ID
41520-184_f2171733-5da6-6476-e053-2a95a90ae144
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Foodhold USA
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-02-01
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
0 mg/116g; mg/116g; mg/116g
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-18441520-184-41IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-184-412023-01-12C16284748780-1c7ccaba7-199e-fd44-e053-dadaa90aa01bCareOne Calamine Plus Spray
41520-184-412021-07-23C16284748780-1c7ccaba7-199e-fd44-e053-dadaa90aa01bCareOne Calamine Plus Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-184-41Calamine Plus Pramoxine HCl116 g in 1 CANISTERAEROSOL, SPRAY1165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-184CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [FOODHOLD USA]5Legacy NDC, 1 package rows20241109_7cad7ad7-347a-6992-e053-2a91aa0a9ad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN7cad7ad7-347a-6992-e053-2a91aa0a9ad65
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD7cad7ad7-347a-6992-e053-2a91aa0a9ad65
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY7cad7ad7-347a-6992-e053-2a91aa0a9ad65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-184-4141520018441116 g in 1 CANISTER (41520-184-41) 116 g2019-02-010000-00-00NoNoCurrent